imagiQ - Set of 2 UDI products as a convenience kit - Stille AB

Duns Number:355280827

Device Description: Set of 2 UDI products as a convenience kit

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More Product Details

Catalog Number

514-50-3SR037

Brand Name

imagiQ

Version/Model Number

Adjustable tray with clamp US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GDC

Product Code Name

Table, Operating-Room, Electrical

Device Record Status

Public Device Record Key

c836c543-6b06-4a56-988a-a809bfdccef3

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STILLE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1073
2 A medical device with a moderate to high risk that requires special controls. 17